Regulatory

Ascelia Pharma strengthens its Mangoral franchise by filing of a patent application for next generation Mangoral product

2019-06-10
Download
Today, Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia”) announces that it has filed a patent application for a next generation Mangoral product. Upon grant, the new patent would further improve the unique value proposition of Mangoral and extend the intellectual property protection rights until year 2040.

Ascelia’s lead imaging drug Mangoral is covered by an Orphan Drug Designation in the US, providing 7 to 7.5 years of market exclusivity after its marketing authorization approval, and in EU/EEA, data exclusivity can prevail from up to 10 years after marketing authorization. With the patent application filed today, the protection rights can be further strengthened and extended until year 2040. The opportunity to improve the Mangoral product and extend the protection rights can add significant value to Ascelia’s Mangoral franchise.

Mangoral is the first oral imaging drug being developed for liver MRI. The new patent application covers an improved formulation of Mangoral which among other benefits will be even more patient friendly and convenient than today’s formulation.

"We are very pleased to have established an improved formulation of Mangoral to the benefit of patients in need of a liver MRI procedure. It demonstrates our long-term commitment to provide better imaging solutions for a patient population with poor alternatives today, i.e. patients in need of liver MRI procedure which cannot tolerate current contrast agents on the market due to impaired kidney function. The potential to extend the exclusivity rights of our Mangoral franchise until year 2040 will add significant value and is a result of our successful Life Cycle Management work and our focus on developing novel and better medicinal products for patients in need”, said Magnus Corfitzen, CEO of Ascelia.

“In the short-term, we now look forward to recruiting patients for the Phase III study in the second half of this year with final results to be obtained by the end of 2020 or beginning of 2021”, he continued.

For more information, please contact:

Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel. 46 735 179 110

Mikael Widell, IR & Communications Manager
Email: mw@ascelia.com
Tel: +46 703 11 99 60

This information is such information as Ascelia Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 7.50 a.m. CET on 10 June 2019.

About Ascelia Pharma
Ascelia Pharma is an oncology-dedicated orphan drug development company located in Malmö, Sweden. The company’s strategy is to develop drugs, which target unmet medical needs, have an established mode of action and a relatively low development risk. Ascelia Pharma has two drug candidates – Mangoral® and Oncoral – currently under development.

Mangoral is a novel contrast agent for MR-scans and is ready for Phase III clinical studies. Mangoral is developed to improve the visualization of focal liver lesions (liver metastases) in patient with impaired kidneys that cannot tolerate current gadolinium contrast agents on the market. Oncoral is an oral chemotherapy tablet ready for Phase II for the treatment of gastric cancer. Ascelia Pharma is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.

2021-10-19

Ascelia Pharma’s Food Effect Study with Orviglance successfully completed

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the last patient visit has been completed in the study to evaluate the effect of food intake on the absorption of Orviglance (Mangoral). This Food Effect Study is part of the ongoing pivotal clinical program for Orviglance and will be included in the marketing authorization package to the health authorities including FDA and EMA.
2021-09-21

Ascelia Pharma Signs Clinical Collaboration Agreement With Taiho Oncology, Inc. for the Development of Oncoral in Combination with LONSURF®

Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has signed a clinical collaboration agreement with Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. The collaboration concerns an upcoming global Phase 2 clinical study in gastric cancer. In this all-oral combination study, Ascelia Pharma’s irinotecan chemotherapy tablet Oncoral (ASC-201) will be evaluated in combination with Taiho Oncology’s LONSURF® (trifluri ...
2021-08-19

Quarterly Report Q2 2021: Preparing Oncoral for the next level

Ascelia Pharma AB (publ) (ticker: ACE) today published its quarterly financial report for Q2 2021 (April – June 2021), which is now available on the company’s website: https://www.ascelia.com/ir-media/reports-presentations/